REACh's specific requirements in relation to nanomaterials have been in force since January 1, 2020 with Regulation (EU) 2018/1881. Three years later, a number of harmonized test methods (Test Guidelines) have been modified or developed within the OECD to take into account the specificities of nanomaterials and to be able to produce these data for regulatory purposes. However, other validated methods are still lacking, and few laboratories are currently able to deploy the test methods already available.

The aim of the day will be to take stock of the situation, including feedback from a number of key stakeholders, as well as to share information on actions underway to facilitate projects to modify or develop OECD guidelines, and to implement a "European test method strategy" to provide a long-term framework for the validation of these methods.

A round-table discussion will also be held to identify possible solutions for improving the contribution of relevant stakeholders to these approaches, and to exchange views on the levels of validation to be envisaged for test methods, depending on the objectives pursued, with a view to improve trust in applicable legislation and safe innovation. 

Event organized in collaboration with the NANOMESUREFRANCE association.

 

Venue: Mercure Paris Porte de Versailles Expo, 36-38 Rue du Moulin 92170 Vanves, France

As most of the speakers are English-speaking, the day's activities and presentations will be in English.

Program

9h00 | Welcoming the participants

Mercure Paris Porte de Versailles Expo, 36-38 Rue du Moulin 92170 Vanves

9h30 | Opening and introduction to the day

Georges Favre, LNE

SESSION 1 : EXISTING FRAMEWORK

9h40| Regulation : current expectations and future changes

Elisabeth Blaton & Céline Fanguet, DGPR

9h55 | Substance evaluation under REACH, what about nanoforms?

Stéphane Jomini & Anthony Cadene, ANSES

10h20 | Overview activities & Achievement

Mar Gonzalez, OECD

SESSION 2: FEEDBACK FROM STAKEHOLDERS

10h45| Regulatory challenges for nanomaterials under REACH – state of play and a way forward

Wim De Coen, ECHA

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11h05 | Break, networking

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11h30 | Practical hurdles for registrants of nanomaterials under REACH

Thomas Leopold, France Chimie

11h50 | Dissolution and dispersion stability of nanomaterials according to OECD/TG 318: Feedback from a testing laboratory

Enrica Alasonati, LNE

12h10 | Q&A on Feedback Session

Moderated by Johann Koullepis

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12h35 | Lunch

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SESSION 3: WHAT INITIATIVES ARE BEING TAKEN TO MOVE THE ISSUE FORWARD?

13h50 | Interactive session (MENTIMETER)

14h05 | How to contribute to OECD Test Guidelines development?

Anna Pohl, BAuA

14h30| New Approach Methodologies to address nanoscale considerations (NAMS4Nano)

Andrea Haase, BfR

14h50| ROUND TABLE - Which strategy for speeding up the development and validation of testing methods?

Moderation : Johann Koullepis
•   Anna Pohl, BAuA
•   Andrea Haase, BfR
•   Thomas Leopold, France Chimie

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15h20 | Break

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15h50 | European Partnership on Metrology (EPM), a funding opportunity for pre-standardisation of test methods

Georges Favre, LNE

16h00 | NanoMesureFrance: a way to coordinate development and implementation of test methods at the French level?

François-Xavier Ouf, LNE / NanoMesureFrance

16h15 | ROUND TABLE - Which strategy for speeding up the development of a pool of recognised and accessible testing laboratories?

Moderation : Johann Koullepis
•    Delphine Franco, SICADAE
•    Georges Favre, LNE / NanoMesureFrance

16h45 | Conclusion: Take home message

Georges Favre, LNE

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